TRESTLE LUXE
GUDID 00190376217291
4.5MM FIXED ANGLE, SELF-TAPPING SCREW, 14 MM
ALPHATEC SPINE, INC.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00190376217291 |
| NIH Device Record Key | 8610fba5-398c-4567-8e14-e7153f56192b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRESTLE LUXE |
| Version Model Number | 722-34514 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
Device Dimensions
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
| Length | 14 Millimeter |
| Outer Diameter | 4.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376217291 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102820
FDA Product Code
| KWQ | Appliance, fixation, spinal intervertebral body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
[00190376217291]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-14 |
| Device Publish Date | 2019-11-06 |
On-Brand Devices [TRESTLE LUXE]
| 00844856001398 | FIXED 2.3MM DRILL BIT, 20MM |
| 00844856001374 | FIXED 2.3MM DRILL BIT, 18MM |
| 00844856001350 | FIXED 2.3MM DRILL BIT, 16MM |
| 00844856001336 | FIXED 2.3MM DRILL BIT, 14MM |
| 00844856001312 | FIXED 2.3MM DRILL BIT, 12MM |
| 00844856001299 | FIXED 2.3MM DRILL BIT, 10MM |
| 00840967192697 | TEMPORARY FIXATION PIN |
| 00190376233765 | TRESTLE LUXE II, ACP, 1-LEVEL, 18 |
| 00190376220093 | TEMPORARY FIXATION PIN |
| 00190376217819 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 21 MM |
| 00190376217802 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 20 MM |
| 00190376217796 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 19 MM |
| 00190376217789 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 18 MM |
| 00190376217772 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 17 MM |
| 00190376217765 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 16 MM |
| 00190376217758 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 15 MM |
| 00190376217741 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 14 MM |
| 00190376217734 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 13 MM |
| 00190376217727 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 12 MM |
| 00190376217710 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 11 MM |
| 00190376217703 | 4.0MM VARIABLE ANGLE, SELF-TAPPING SCREW, 10 MM |
| 00190376217697 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 24 MM |
| 00190376217680 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 23 MM |
| 00190376217673 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 22 MM |
| 00190376217666 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 21 MM |
| 00190376217659 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 20 MM |
| 00190376217642 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 19 MM |
| 00190376217635 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 18 MM |
| 00190376217628 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 17 MM |
| 00190376217611 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 16 MM |
| 00190376217604 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 15 MM |
| 00190376217598 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 14 MM |
| 00190376217581 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 13 MM |
| 00190376217574 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 12 MM |
| 00190376217567 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 11 MM |
| 00190376217550 | 4.5MM FIXED ANGLE, SELF-DRILLING SCREW, 10 MM |
| 00190376217543 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 24 MM |
| 00190376217536 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 23 MM |
| 00190376217529 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 22 MM |
| 00190376217512 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 21 MM |
| 00190376217505 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 20 MM |
| 00190376217499 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 19 MM |
| 00190376217482 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 18 MM |
| 00190376217475 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 17 MM |
| 00190376217468 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 16 MM |
| 00190376217451 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 15 MM |
| 00190376217444 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 14 MM |
| 00190376217437 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 13 MM |
| 00190376217420 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 12 MM |
| 00190376217413 | 4.0MM FIXED ANGLE, SELF-DRILLING SCREW, 11 MM |
Trademark Results [TRESTLE LUXE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRESTLE LUXE 85068010 4126127 Live/Registered |
Alphatec Spine, Inc. 2010-06-21 |
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